Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Pfizer

Status and phase

Completed

Phase 4

Conditions

Low Back Pain

Treatments

Drug: valdecoxib

Drug: diclofenac

Study type

Interventional

Funder types

Industry

Identifiers

NCT00649610

A3471012

Details and patient eligibility

About

The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.

Enrollment

340 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion criteria

History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
Moderate to severe scoliosis
Back pain due to major trauma or visceral disorder
Unwilling to refrain from commencing concomitant physiotherapy
Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception